Simulations Plus Embarks on Collaboration with Northeastern University and The TIM Company Through New FDA Grant
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The awarded grant for the collaboration between Simulations Plus, Northeastern University and The TIM Company, funded by the FDA, signifies a strategic investment in enhancing the development process for generic oral modified-release (MR) drug products. The integration of in vitro data and advanced PBPK/PBBM modeling is poised to refine the understanding of CQAs and dissolution profiles, which are pivotal in ensuring the efficacy and safety of MR formulations. This research may reduce the reliance on extensive clinical trials, expediting the time-to-market for generics and potentially lowering healthcare costs.
From a pharmaceutical development standpoint, the ability to accurately predict clinical pharmacokinetics through in silico methods can streamline the regulatory approval process. This could result in a competitive advantage for companies utilizing these models, as they may achieve faster FDA approvals and thus gain market share more quickly. Moreover, the industry as a whole may benefit from reduced development costs and increased predictability of outcomes, fostering innovation and potentially leading to a more diverse range of treatment options for patients.
The implications of this FDA-funded project extend beyond the immediate stakeholders to the broader healthcare industry. The collaboration underscores a shift towards more sophisticated drug development paradigms, integrating computational modeling with empirical data. For healthcare providers and payers, the anticipated acceleration in the availability of generic oral MR drugs could translate into improved treatment affordability and accessibility.
In the long term, such advancements may encourage a paradigm shift in drug development, where in silico models become a standard component of the drug approval process. This could lead to a more efficient allocation of resources within healthcare systems, as the need for costly and time-consuming clinical trials diminishes. However, the transition to a model-reliant approach will require rigorous validation to ensure patient safety and treatment efficacy remain uncompromised.
The market implications of the grant are multifaceted. For Simulations Plus, the partnership and grant award could signal to investors the company's strengthened position within the modeling and simulation sector, potentially affecting its stock valuation positively. The project's success could also attract further collaborations and contracts, contributing to revenue growth.
For the pharmaceutical industry, the adoption of PBPK/PBBM models in drug development processes may lead to a shift in R&D investments, with a greater focus on computational resources and expertise. Companies that adapt early to this trend might secure a competitive edge, influencing market dynamics. However, the impact on stock prices will hinge on the perceived efficacy of these models in reducing time-to-market for drugs and their acceptance by regulatory bodies.
Partnership aims to integrate experimental data and PBPK modeling to identify key formulation factors to accelerate modified-release product development
For this award, Dr. Jie Shen, Associate Professor of Pharmaceutical Sciences, and her lab at Northeastern University, along with partners at The TIM Company, will generate in vitro data characterizing the critical quality attributes (CQAs) and dissolution of multiple strengths of MR formulations. The newly generated data will be used to parameterize physiologically based pharmacokinetic/physiologically based biopharmaceutic (PBPK/PBBM) models predicting clinical pharmacokinetics of those MR formulations following their oral administration. The combination of in vitro and in silico studies will support the identification of the appropriate factors to scale the MR formulation for additional strengths, and to identify the CQAs and formulation design spaces for oral MR tablets.
“This collaboration is an exciting step forward, as we combine our PBPK/PBBM modeling and simulation expertise with Northeastern University's research excellence and The TIM Company's groundbreaking tiny-TIMsg model,” said Dr. Xavier Pepin, Associate Vice President, Regulatory Strategies and lead investigator for this grant for Simulations Plus. “Together, we are charting a course towards more efficient drug development and safer healthcare solutions. We believe the comprehensive framework established through this collaboration will have value for both the FDA and the companies involved in developing oral MR formulations.”
“The research efforts of our team and Dr. Shen have the potential to accelerate the availability of critical treatments to patients across the world, with minimized need for clinical trials,” said Susann Bellmann, Chief Technology Officer at The TIM Company. “We are proud to support those efforts and this collaboration through the use of our dynamic in vitro gastrointestinal model, tiny-TIMsg.”
FDA scientific and program staff will actively collaborate with Northeastern University, The TIM Company, and Simulations Plus. Dr. Pepin, with assistance from Dr. Maxime Le Merdy at Simulations Plus, will oversee the modeling and simulation activities of the contract.
Funding for this collaboration is made possible by the Food and Drug Administration through grant award 1U01FD007959-01. Views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.
About Professor Jie Shen’s Laboratory at Northeastern University
Professor Jie Shen’s laboratory at Northeastern University is dedicated to innovative and collaborative interdisciplinary pharmaceutical and biomedical research to enhance public access to high quality and cost-effective medications to ultimately improve public health. Professor Shen’s laboratory is specialized in the formulation development and characterization, bioequivalence assessment strategies, and IVIVC (in vitro-in vivo correlation) of complex drug products (such as long-acting or locally-acting dosage forms, nanomedicines, modified release formulations). For more information, visit our website or follow us on LinkedIn. Founded in 1898, Northeastern is a global research university and the recognized leader in experience-driven lifelong learning. Our world-renowned experiential approach empowers our students, faculty, alumni, and partners to create impact far beyond the confines of discipline, degree, and campus.
About The TIM Company
The TIM Company expands its legacy of expertise within in vitro gastrointestinal models, combining over 35 years of experience. Headquartered in Delft,
About Simulations Plus, Inc.
Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge artificial intelligence (AI)/machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | Twitter | YouTube.
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